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Mobile Technology to Measure Knee Health in Osteoarthritis

5. mai 2026 oppdatert av: VA Office of Research and Development

Using Mobile Technology to Extract Mechanical Markers of Joint Health and Function in Early Knee Osteoarthritis

Veterans face a high prevalence of knee osteoarthritis (OA), but current diagnostic methods often miss early stages when interventions are more effective. This project will evaluate smartphone-based motion capture via OpenCap to measure joint mechanics in knee OA patients during functional activities, comparing its performance to a conventional motion capture system, patient-reported symptoms, and knee joint structure. The findings will have the potential to enable clinicians to trial OpenCap in its current form, provide insights into tracking joint health, and guide refinements to advance toward earlier diagnosis of knee OA by complementing symptom assessments with measures of joint mechanics.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

Significance to VA: Veterans, particularly the younger age group, have a higher prevalence of osteoarthritis (OA) than the general population. Among Veterans, OA most commonly affects the knee, a joint with a high injury rate in the US Military. Current diagnostic criteria for knee OA, which often rely on radiographic evidence, do not consistently identify younger patients or those in the early stages of OA, when interventions may be most effective. At the onset of OA symptoms, there is a critical window to quantify mechanical markers that could predict disease progression and provide insights beyond pain. While mechanical markers are predictive and capable of tracking OA progression, their clinical utility has been limited by conventional marker-based motion capture (Mocap), which requires specialized equipment, trained experts, and dedicated resources, making it inaccessible in many clinical settings.

Innovation and Impact: A novel mobile technology, OpenCap, uses smartphone video-based motion capture to estimate movement mechanics, offering a low-cost and highly accessible alternative to traditional Mocap. OpenCap requires at a minimum of two smartphones and applies machine learning and musculoskeletal modeling to quantify mechanical markers. This technology has the potential to overcome significant barriers to implementing mechanical markers in clinical care. However, OpenCap has not yet been evaluated in knee OA patients, and its validity for quantifying mechanical markers during activities relevant to knee OA management remains underexplored.

Therefore, this mentored career development award application has an objective to evaluate the utility of mobile technology OpenCap in quantifying mechanical markers that may provide insights into joint health in patients with early knee OA and to extract these markers from functional activities commonly used in knee OA management.

Specific Aims: Aim 1 will evaluate the current potential use of the mobile technology OpenCap in patients with knee OA by testing the hypotheses that (1a) mechanical markers estimated by the mobile technology significantly differ but are associated with those measured using conventional Mocap and (1b) the mobile technology detects within-person, within-visit mechanical differences introduced by functional activity variations. Aim 2 will explore the broader use of the mobile technology OpenCap in patients with knee OA by (2a) associating mechanical markers estimated by the mobile technology with patient-reported outcomes (PROs), performance-based measures, and structural metrics and (2b) determining the test-retest reliability of the mechanical markers.

Anticipated Research Outcomes: The project findings will have the potential to enable clinicians to trial the technology in its current form, leveraging its potential to quantify and document movement mechanics in patients at risk of or with knee OA. At the same time, the project's results will explore more advanced applications, such as tracking functional changes over time during OA treatment and contributing critical data to refine and further develop the technology. On the other hand, recalling an existing research cohort offers an invaluable opportunity for longitudinal follow-up.

Anticipated Training Outcomes: This award will provide the applicant with training in musculoskeletal modeling, data science, and clinical and translational science, enabling the applicant to validate and refine mobile motion capture technologies. This training will prepare the applicant to integrate mobile technologies into clinical practice and support applicant's advancement to independence through next-level CDA award.

Path to Translation/Implementation: This study will provide clinicians with practical insights on using OpenCap in its current form to quantify and document joint health. Findings will inform future refinements and support subsequent efforts to evaluate the feasibility of video-based motion capture via OpenCap in OA care. This project aligns with VA priorities by improving early diagnosis and management of knee OA to enhance care for Veterans.

Studietype

Observasjonsmessig

Registrering (Antatt)

47

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Jade He, PhD
  • Telefonnummer: 64431 (650) 493-5000
  • E-post: Jade.He@va.gov

Studiesteder

    • California
      • Palo Alto, California, Forente stater, 94304-1207
        • Rekruttering
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Ta kontakt med:
          • Jade He, PhD
          • Telefonnummer: 64431 650-493-5000
          • E-post: Jade.He@va.gov
        • Hovedetterforsker:
          • Jade He, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Individuals who were diagnosed with early knee osteoarthritis and had a history of being elected to receive injection treatment

Beskrivelse

Inclusion Criteria:

  • Veteran and non-Veterans
  • males and females
  • diagnosed with early knee osteoarthritis
  • qualified for and participated in the Precision Assessment of Platelet Rich Plasma for Joint Preservation study (ClinicalTrials.gov ID: NCT03460236)
  • able and willing to provide informed consent for follow-up study

Exclusion Criteria:

  • symptomatic OA in joints other than the knee in the lower body
  • joint replacement
  • rheumatic disease
  • BMI > 35 kg/m^2
  • severe systematic disease defined as American Society of Anesthesiologists (ASA) 3 or above
  • pregnant or intending to become pregnant during the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Knee OA
Adults who were previously diagnosed with early knee osteoarthritis, enrolled in Precision Assessment of Platelet Rich Plasma for Joint Preservation study (NCT03460236), and able and willing to participate in the follow-up assessment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knee flexion angle
Tidsramme: Baseline and Week 1
Knee flexion angle extracted from functional activities (e.g., walking, chair-to-stand)
Baseline and Week 1

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knee flexion moment
Tidsramme: Baseline and Week 1
Knee flexion moment estimated from functional activities (e.g., walking, chair-to-stand)
Baseline and Week 1

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Osteoarthritis Index (Transformed)
Tidsramme: Baseline and Week 1
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores will be calculated from answers to the Knee Injury and Osteoarthritis Outcome Score questionnaire, including domains of Pain, Stiffness, and Function. WOMAC scores will be transformed to a scale of 0-100, with higher scores indicating fewer symptoms.
Baseline and Week 1
Duration of 40-meter fast walk test
Tidsramme: Baseline or Week 1
Duration in seconds to complete 40-meter fast walk test
Baseline or Week 1
Repetitions for 30-second chair-to-stand test
Tidsramme: Baseline or Week 1
The number of repetitions of chair-to-stand performed during 30-second
Baseline or Week 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jade He, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2026

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

31. mars 2028

Datoer for studieregistrering

Først innsendt

8. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • RRD8-005-24W
  • 66791 (Annen identifikator: Stanford IRB)
  • IK1RD000707 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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